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Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs.
The treatment of postoperative pain is a priority issue for both the doctor and the patient. Obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %). The use of pulsed electromagnetic fields (PEMF) for the treatment of pain and inflammation has been widely studied and validated. Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields), for the treatment of postoperative pain in oncological breast surgery. This is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. AlgoCare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, CE certified and registered with the Ministry of Health. It emits a pulsed radio frequency electromagnetic field at 27.1 MHz, a frequency already studied and approved for medical use.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
European Institute of Oncology
Milan, Italy
Start Date
May 9, 2023
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
March 26, 2024
160
ESTIMATED participants
Active AlgoCare
DEVICE
Non-active AlgoCare
DEVICE
Lead Sponsor
European Institute of Oncology
NCT07482709
NCT07041736
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07310953